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Percutaneous Rectus Sheath Block Versus Intra-operative Rectus Sheath Block for Pediatric Umbilical Hernia Repair

NCT02341144 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 61

Last updated 2023-07-03

Study results available
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Summary

This is a prospective, double-blinded, randomized controlled study comparing the efficacy of pre-incisional percutaneous rectus sheath block to intra-operative rectus sheath block under direct visualization prior to closure of the incision for providing post-operative analgesia following umbilical hernia repair in children. The current management for reducible umbilical hernias is umbilical hernia repair under general anesthesia as an outpatient procedure.

Patients aged 3-18 years old with a diagnosis of umbilical hernia will be screened for study inclusion. Eligible patients and their parents/guardians will be approached and, if agreeable, consented for the study pre-operatively. Patients will be randomized to receive either pre-incisional percutaneous rectus sheath block by the anesthesiologist or intra-operative rectus sheath block under direct visualization prior to closure of the skin incision by the surgeon. The patient, patient guardians, select research team members, and post-anesthesia care unit (PACU) staff will be blinded to the method of analgesic administration.

Conditions

  • Pain, Postoperative

Interventions

PROCEDURE

Pre-op percutaneous rectus sheath block

After induction of anesthesia, the attending anesthesiologist will use a portable ultrasound probe to locate the rectus sheath. A 22 gauge needle will be used to inject a predetermined volume of 0.2% ropivacaine (1cc/kg, max dose 10cc, divided into equal doses bilaterally). The analgesic will be injected percutaneously using ultrasound guidance between the rectus abdominis muscle and the posterior rectus sheath at the lateral border bilaterally.

PROCEDURE

Intra-operative rectus sheath block

After the completion of the umbilical hernia repair, after fascial closure, but prior to skin closure, a predetermined volume of 0.2% ropivacaine (1cc/kg, max dose 10c, divided into equal doses bilaterally) will be administered under direct visualization into the rectus sheath bilaterally by the attending surgeon.

DRUG

Ropivacaine

Sponsors & Collaborators

  • Johns Hopkins All Children's Hospital

    lead OTHER

Principal Investigators

  • Nicole M Chandler, MD · Johns Hopkins All Children's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
3 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-12-31
Primary Completion
2016-03-01
Completion
2016-04-01

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02341144 on ClinicalTrials.gov